Home NDC 0071-5212 ACCURETIC
Product NDC 0071-5212
11-digit product format 000715212
Labeler code 0071
Product ID 0071-5212_1d3fab62-2114-4d5b-b07a-9b0f2b5a3efd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quinapril and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Parke-Davis Div of Pfizer Inc
Application NDA020125
Marketing category NDA
Marketing start 2021-12-06
Marketing end 0000-00-00
Substance QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength 20 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 QUINAPRIL HYDROCHLORIDE ACTIVE INGREDIENT 33067B3N2M ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 QUINAPRILAT ACTIVE MOIETY 34SSX5LDE5 ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 MAGNESIUM CARBONATE INACTIVE INGREDIENT 0E53J927NA ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0071-5212 ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED ACCURETIC (QUINAPRIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 32 Legacy NDC 20230919_80e9d61d-9674-4ac4-b84c-79a875d408dd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0071-5212-23 00071521223 90 TABLET, FILM COATED in 1 BOTTLE (0071-5212-23) 2021-12-06 0000-00-00 No No Current